Omeros Corporation, a clinical-stage biopharmaceutical company, has announced promising data from the single-ascending-dose (SAD) study portion of the company's phase I clinical trial evaluating OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) programme. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.
In this successful SAD study, OMS824 was well tolerated and demonstrated linear pharmacokinetics, a long half-life consistent with once daily dosing and good systemic exposure that, at the highest dose administered, resulted in the expected pharmacological effects in healthy subjects. With these encouraging data, Omeros has advanced OMS824 to the next stage of the phase I clinical trial – the evaluation of multiple-dose administration of the compound. Omeros expects complete data to be available in early 2013.
"OMS824 appears to have excellent pharmaceutical properties, and we look forward to completing this phase I clinical trial and starting studies in schizophrenia patients," said Gregory A. Demopulos, chairman and chief executive officer of Omeros. "While preparing for the next set of OMS824 studies, our pipeline continues to advance toward additional near-term milestones – phase III data for OMS103HP this month, an NDA submission next quarter and, for as many as three additional programs, entry into the clinic in 2013."
PDE10 is an enzyme that is expressed in areas of the brain linked to diseases that affect cognition, including schizophrenia and Huntington's disease. Cognitive dysfunction occurs early in these diseases and is responsible for substantial disability. Omeros' proprietary compound OMS824 inhibits PDE10 and is being developed for the treatment of cognitive disorders, including schizophrenia where OMS824 could also have a beneficial effect on the positive (e.g., hallucinations) and negative (e.g., flat affect) symptoms of the disease.
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system.